A High Intensity Electronic Health Intervention for the Reduction of Learning Disparities in Childhood Cancer Survivors

a study on Leukemia Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Lymphoma

Summary

Eligibility
for people ages 6 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Caroline Hastings, MDDina Hankin, PhD
Headshot of Caroline Hastings
Caroline Hastings

Description

Summary

This clinical trial evaluates a high intensity electronic health (eHealth) intervention program for reducing learning disparities in children with cancer. Most children with leukemia and lymphoblastic lymphoma can be cured due to advancements in diagnosis and treatment. However, because treatments for these conditions target the central nervous system, these children are at increased risk for developing neurocognitive late effects (problems with attention, thinking, learning, and remembering). Fortunately, many survivors do well, but some children continue to struggle with learning and have academic difficulties after their cancer treatments. The purpose of this research study is to see whether providing parents with educational knowledge and parenting tips using videoconferencing and a special website better helps their cancer survivor child in learning and school achievement compared to typical services.

Official Title

Leveraging Digital Health Solutions to Reduce Learning and Functional Disparities in Children With Cancer

Details

PRIMARY OBJECTIVE:

  1. Determine the effectiveness of high intensity program (HIP)-eHealth on pediatric cancer survivors' learning and school-related outcomes up to 12 months post-enrollment.

SECONDARY OBJECTIVES:

  1. Determine the effectiveness of HIP-eHealth on parental efficacy up to 12 months post-enrollment.

II. Examine the extent to which parents' self-reported efficacy and/or children's use of online learning activities correlates with the children's school functioning.

III. Examine differences in HIP-eHealth uptake and effects across socio-demographic groups.

OUTLINE:

PRE-STUDY: Parent-child dyads attend 4 intervention sessions over 10 weeks and provide feedback in support of intervention refinement.

Parent-child dyads are randomized to 1 of 2 arms.

ARM I: Patients and parents undergo high intensity eHealth intervention through the interactive website and via videoconferencing for 30-50 minutes once every 3 to 4 weeks for up to 5 sessions over 6 months. Patients and parents also receive usual care. After 6 months, parents attend booster sessions at months 7, 9, and 11.

ARM II: Patients and parents receive usual care.

Keywords

Acute Leukemia, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Lymphoblastic Lymphoma, Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Best Practice, Internet-Based Intervention, Quality-of-Life Assessment, high intensity e-Health program

Eligibility

You can join if…

Open to people ages 6 years and up

  • Documented informed consent of the participant and/or legally authorized representative
    • Assent, when appropriate, will be obtained per institutional guidelines
  • Primary participating parent/caregiver is English- or Spanish-speaking (any race/ethnicity)
  • Child is aged 6-12 years (yr.) (for the website usability pre-study, child is age 8
    • 12 yrs.)
  • Child understands English (but can be bilingual)
  • Child treated for acute leukemia (e.g., acute lymphoblastic leukemia, acute myelogenous leukemia) or lymphoblastic lymphoma
  • Child is in cancer remission and has completed cancer therapies, including maintenance treatment
  • Primary participating parent/caregiver has daily contact with the child
  • Child is enrolled in school

You CAN'T join if...

  • Recent or current participation in a behavioral intervention study with a similar focus
  • History of major psychiatric condition (e.g., psychosis) in parent or child
  • Severe neurodevelopmental disorder in the child (e.g., down syndrome, intellectual disability)
  • Child has previously used the IXL online learning program extensively and unwilling to regularly use it again
  • Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
  • Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Locations

  • University of Calif San Francisco accepting new patients
    San Francisco California 94115 United States
  • Childrens Hospital of Los Angeles accepting new patients
    Los Angeles California 90027 United States
  • City of Hope Medical Center accepting new patients
    Duarte California 91010 United States
  • Rady Children's Hospital San Diego accepting new patients
    San Diego California 92123 United States

Lead Scientists at UCSF

  • Caroline Hastings, MD
    Dr. Caroline Hastings is a Professor of Pediatrics and is specialty boarded in Pediatric Hematology Oncology. She has been at Children's Hospital Oakland and now UCSF since completion of her training in 1992. Her longevity in the group has allowed for personal and professional growth and development of long-term relationships with her patients.
  • Dina Hankin, PhD

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
City of Hope Medical Center
ID
NCT05428176
Study Type
Interventional
Participants
Expecting 332 study participants
Last Updated
Contact us about this trial